Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial

Stopped early · Phase 2

Conditions studied: Articular Cartilage Injury

In brief

The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair Device or a standard surgical technique called microfracture. The purpose of the study is to evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to microfracture.

Key facts

Study ID

NCT01183637

Run by

Kensey Nash Corporation

People needed

2

Starts

2010-06-01

Expected to finish

2014-05-01

Last updated by the study team

2015-05-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 years old and skeletally mature
• KOOS Pain subscale score is less than 65 (i.e. moderate pain)
• KOOS Activities of Daily Living score is less than 70 (i.e. moderate functional limitations)
• ICRS grade 3 or 4 cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea measuring less than or equal to 15mm in diameter
• Stable meniscus with greater than 50% remaining bilaterally
• Mental capacity and willingness to comply with the post-operative rehabilitation plan and follow-up evaluations
• Written informed consent

You may not qualify if…

• Body mass index greater than 35
• Contraindication for MRI
• Previous microfracture, autograft implantation, allograft implantation or autologous chondrocyte implantation procedure on the damaged cartilage surface
• Knee ligament surgery within the past 6 months
• Clinically significant knee malalignment
• Osteoarthritis in the knee
• Multiple cartilage lesions
• Inflammatory arthropathy (i.e. rheumatoid arthritis, systemic lupus or active gout)
• Active infection in either lower limb
• Hyaluronic acid or cortisone injections within the past 3 months
• History of substance abuse
• Current participation in a study of an investigational product for a similar purpose
• Active litigation for the knee injury

Where it is running

• Peninsula Orthopedic Associates — Salisbury, Maryland, United States
• U.S. Center for Sports Medicine — Kirkwood, Missouri, United States

Full record on ClinicalTrials.gov

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